| |
bCBT (n = 45)
|
CAU (n = 43)
| |
|---|
|
Mean
|
SE/SD*
|
Mean
|
SE/SD*
|
Mean difference
|
95% CI
|
p value
|
|---|
|
Primary outcome
|
|
FCR (CWS)
|
|
T0
|
19.622
|
3.737
|
19.558
|
3.744
| | | |
|
T1 unadjusted
|
14.814
|
4.579
|
18.487
|
3.986
| | | |
|
T1 adjusted
|
14.743
|
0.432
|
18.277
|
0.454
|
−3.534
|
−4.764 to −2.305
|
0.000
|
|
T2 unadjusted
|
13.718
|
4.472
|
17.844
|
3.836
| | | |
|
T2 adjusted
|
13.916
|
0.493
|
18.020
|
0.534
|
−4.104
|
−5.531 to − 2.677
|
0.000
|
|
T3 unadjusted
|
14.684
|
4.539
|
16.516
|
4.081
| | | |
|
T3 adjusted
|
14.783
|
0.504
|
16.570
|
0.549
|
−1.787
|
−3.251 to −0.323
|
0.017
|
|
Secondary outcomes
|
|
Multidimensional aspects of FCR
|
|
Severity (FCRI)
|
|
T0
|
21.909
|
4.850
|
23.116
|
6.456
| | | |
|
T1 unadjusted
|
16.605
|
7.251
|
22.282
|
5.991
| | | |
|
T1 adjusted
|
16.989
|
0.756
|
21.330
|
0.788
|
−4.341
|
−6.497 to −2.185
|
0.000
|
|
T2 unadjusted
|
15.025
|
6.897
|
21.313
|
5.171
| | | |
|
T2 adjusted
|
15.957
|
0.688
|
20.462
|
0.742
|
−4.505
|
−6.513 to −2.497
|
0.000
|
|
T3 unadjusted
|
15.842
|
7.343
|
19.733
|
5.539
| | | |
|
T3 adjusted
|
16.599
|
0.805
|
19.023
|
0.879
|
−2.423
|
−4.785 to −0.062
|
0.044
|
|
Distress, depression, anxiety
|
|
Distress (HADS)
|
|
T0
|
14.089
|
7.836
|
15.209
|
8.911
| | | |
|
T1 unadjusted
|
9.951
|
8.402
|
17.131
|
9.519
| | | |
|
T1 adjusted
|
10.749
|
0.731
|
16.003
|
0.763
|
−5.254
|
−7.334 to −3.174
|
0.000
|
|
T2 unadjusted
|
9.718
|
7.412
|
15.862
|
9.771
| | | |
|
T2 adjusted
|
11.139
|
0.806
|
14.897
|
0.898
|
−3.759
|
−6.134 to −1.383
|
0.002
|
|
T3 unadjusted
|
9.778
|
8.292
|
14.889
|
9.390
| | | |
|
T3 adjusted
|
11.414
|
0.966
|
13.228
|
1.082
|
−1.813
|
−4.669 to 1.043
|
0.213
|
|
Anxiety (HADS)
|
|
T0
|
8.156
|
4.101
|
8.395
|
4.914
| | | |
|
T1 unadjusted
|
5.317
|
4.239
|
9.447
|
5.012
| | | |
|
T1 adjusted
|
5.639
|
0.437
|
8.951
|
0.456
|
−3.312
|
−4.555 to −2.068
|
0.000
|
|
T2 unadjusted
|
5.333
|
4.132
|
8.862
|
5.585
| | | |
|
T2 adjusted
|
6.030
|
0.528
|
8.549
|
0.588
|
−2.519
|
−4.074 to −0.964
|
0.002
|
|
T3 unadjusted
|
4.944
|
4.056
|
8.333
|
4.844
| | | |
|
T3 adjusted
|
5.751
|
0.570
|
7.734
|
0.638
|
−1.984
|
−3.667 to − 0.301
|
0.021
|
|
Depression (HADS)
|
|
T0
|
5.933
|
4.218
|
6.814
|
4.722
| | | |
|
T1 unadjusted
|
4.634
|
4.598
|
7.684
|
5.152
| | | |
|
T1 adjusted
|
5.050
|
0.424
|
7.131
|
0.442
|
−2.081
|
−3.286 to −0.876
|
0.001
|
|
T2 unadjusted
|
4.385
|
4.017
|
7.000
|
4.751
| | | |
|
T2 adjusted
|
5.042
|
0.418
|
6.406
|
0.467
|
−1.363
|
−2.597 to −0.130
|
0.030
|
|
T3 unadjusted
|
4.833
|
4.675
|
6.556
|
4.956
| | | |
|
T3 adjusted
|
5.582
|
0.504
|
5.611
|
0.565
|
−.029
|
−1.520 to 1.462
|
0.970
|
|
Cancer-specific distress (IES)
|
|
T0
|
23.044
|
14.555
|
24.902
|
15.604
| | | |
|
T1 unadjusted
|
14.732
|
14.998
|
26.026
|
17.747
| | | |
|
T1 adjusted
|
15.539
|
2.064
|
24.598
|
2.208
|
−9.059
|
−15.003 to −3.115
|
0.003
|
|
T2 unadjusted
|
9.973
|
13.710
|
16.643
|
15.905
| | | |
|
T2 adjusted
|
11.127
|
2.085
|
17.107
|
2.391
|
−5.979
|
−12.215 to 0.256
|
0.060
|
|
T3 unadjusted
|
14.944
|
14.633
|
18.259
|
15.294
| | | |
|
T3 adjusted
|
15.781
|
2.147
|
17.254
|
2.450
|
−1.473
|
−7.883 to 4.938
|
0.653
|
|
Fatigue (CIS-8R)
|
|
T0
|
30.222
|
12.951
|
36.116
|
12.585
| | | |
|
T1 unadjusted
|
25.250
|
11.535
|
36.684
|
13.001
| | | |
|
T1 adjusted
|
27.961
|
1.137
|
33.478
|
1.176
|
−5.516
|
−8.771 to −2.262
|
0.001
|
|
T2 unadjusted
|
26.769
|
11.855
|
32.586
|
12.290
| | | |
|
T2 adjusted
|
28.694
|
1.297
|
30.512
|
1.444
|
−1.818
|
−5.658 to 2.022
|
0.353
|
|
T3 unadjusted
|
26.806
|
11.436
|
30.556
|
13.042
| | | |
|
T3 adjusted
|
29.387
|
1.350
|
26.888
|
1.514
|
2.499
|
−1.522 to 6.521
|
0.223
|
|
Quality of life (EORTC QLQ-C30)
|
|
Global quality of life
|
|
T0
|
62.222
|
19.672
|
61.434
|
20.252
| | | |
|
T1 unadjusted
|
73.062
|
19.402
|
57.479
|
20.483
| | | |
|
T1 adjusted
|
72.504
|
2.556
|
58.075
|
2.682
|
14.429
|
7.153 to 21.705
|
0.000
|
|
T2 unadjusted
|
72.083
|
21.229
|
62.500
|
21.792
| | | |
|
T2 adjusted
|
71.918
|
3.004
|
62.632
|
3.264
|
9.286
|
0.576 to 17.997
|
0.037
|
|
T3 unadjusted
|
73.026
|
19.609
|
65.278
|
19.948
| | | |
|
T3 adjusted
|
72.672
|
2.823
|
67.742
|
3.108
|
4.930
|
−3.331 to 13.192
|
0.242
|
|
Physical functioning
|
|
T0
|
87.704
|
13.406
|
83.953
|
16.269
| | | |
|
T1 unadjusted
|
89.380
|
11.735
|
80.855
|
20.010
| | | |
|
T1 adjusted
|
87.552
|
1.527
|
82.886
|
1.606
|
4.666
|
.296 to 9.037
|
0.036
|
|
T2 unadjusted
|
88.750
|
15.148
|
86.458
|
14.809
| | | |
|
T2 adjusted
|
86.246
|
1.737
|
87.766
|
1.893
|
−1.519
|
−6.583 to 3.545
|
0.557
|
|
T3 unadjusted
|
89.649
|
13.924
|
84.301
|
14.560
| | | |
|
T3 adjusted
|
87.986
|
1.592
|
86.829
|
1.721
|
1.156
|
−3.479 to 5.792
|
0.625
|
|
Role functioning
|
|
T0
|
77.037
|
26.181
|
74.806
|
25.295
| | | |
|
T1 unadjusted
|
85.659
|
21.076
|
74.123
|
23.474
| | | |
|
T1 adjusted
|
84.543
|
2.963
|
75.547
|
3.142
|
8.996
|
0.503 to 17.489
|
0.038
|
|
T2 unadjusted
|
83.750
|
23.415
|
82.292
|
21.972
| | | |
|
T2 adjusted
|
82.766
|
3.407
|
82.705
|
3.742
|
0.061
|
−9.887 to 10.008
|
0.991
|
|
T3 unadjusted
|
89.035
|
17.013
|
84.409
|
23.148
| | | |
|
T3 adjusted
|
87.388
|
2.777
|
85.357
|
3.043
|
2.031
|
−6.095 to 10.157
|
0.624
|
|
Emotional functioning
|
|
T0
|
64.815
|
22.883
|
66.860
|
22.456
| | | |
|
T1 unadjusted
|
81.589
|
23.185
|
60.256
|
29.830
| | | |
|
T1 adjusted
|
81.647
|
2.934
|
59.978
|
3.078
|
21.669
|
13.326 to 30.011
|
0.000
|
|
T2 unadjusted
|
80.208
|
22.463
|
61.719
|
28.544
| | | |
|
T2 adjusted
|
78.959
|
3.259
|
60.785
|
3.540
|
18.174
|
8.731 to 27.617
|
0.000
|
|
T3 unadjusted
|
77.851
|
23.592
|
68.548
|
25.973
| | | |
|
T3 adjusted
|
77.507
|
2.987
|
68.668
|
3.242
|
8.839
|
0.179 to 17.499
|
0.046
|
|
Cognitive functioning
|
|
T0
|
72.963
|
24.692
|
68.992
|
25.350
| | | |
|
T1 unadjusted
|
80.620
|
19.897
|
62.393
|
28.541
| | | |
|
T1 adjusted
|
79.977
|
2.920
|
64.662
|
3.071
|
15.315
|
6.989 to 23.641
|
0.000
|
|
T2 unadjusted
|
82.500
|
19.954
|
72.917
|
28.945
| | | |
|
T2 adjusted
|
80.130
|
3.276
|
74.990
|
3.593
|
5.140
|
−4.421 to 14.701
|
0.292
|
|
T3 unadjusted
|
79.386
|
22.738
|
68.280
|
25.587
| | | |
|
T3 adjusted
|
76.994
|
3.171
|
71.780
|
3.442
|
5.214
|
−4.013 to 14.441
|
0.268
|
|
Social functioning
|
|
T0
|
80.000
|
23.192
|
71.318
|
24.754
| | | |
|
T1 unadjusted
|
89.922
|
17.495
|
76.923
|
26.384
| | | |
|
T1 adjusted
|
87.868
|
2.907
|
79.225
|
3.055
|
8.643
|
0.306 to 16.979
|
0.042
|
|
T2 unadjusted
|
85.833
|
22.504
|
80.208
|
22.175
| | | |
|
T2 adjusted
|
83.302
|
3.052
|
81.127
|
3.310
|
2.176
|
−6.727 to 11.078
|
0.632
|
|
T3 unadjusted
|
88.158
|
19.723
|
86.022
|
19.292
| | | |
|
T3 adjusted
|
85.924
|
2.556
|
89.059
|
2.759
|
3.135
|
−10.641 to 4.370
|
0.413
|
- NOTE. Linear mixed-effects models were used to calculate all p-values. Adjusted means were adjusted for the baseline covariates primary cancer site and baseline value of the corresponding outcome; unadjusted means were unadjusted for covariates. Boldface type indicates a statistically significant effect for adjusted means (p < 0.05)
- *SEs are reported for adjusted means, SDs for unadjusted means
- Abbreviations: bCBT blended cognitive behaviour therapy, CAU care as usual; FCR fear of cancer recurrence, CWS Cancer Worry Scale, FCRI Fear of Cancer Recurrence Inventory, HADS Hospital Anxiety and Depression Scale, IES Impact of Events Scale, CIS-8R Checklist Individual Strength 8R, EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, SD standard deviation, SE standard error
